Phase 3
N=445
A Study to Evaluate the Use and Safety of CARDIOLITE® in Pediatric Patients With Kawasaki Disease
Kawasaki Disease
Bottom Line
View on ClinicalTrials.gov: NCT00162032 ↗Enrolled (actual)
445
Serious AEs
0.2%
Results posted
Dec 2013
Primary outcome: Primary: Determine the Predictive Value of Cardiolite® Rest and Stress MPI to Define Pediatric Populations With Kawasaki Disease at High and Low Risk of Developing Cardiac Events. — 0.041; 0.033; 0.115; 0.233 proportion of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Sestamibi (Drug)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- Lantheus Medical Imaging
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Determine the Predictive Value of Cardiolite® Rest and Stress MPI to Define Pediatric Populations With Kawasaki Disease at High and Low Risk of Developing Cardiac Events. |
0.041; 0.033; 0.115; 0.233 | — |
| SECONDARY Estimate the Performance of Cardiolite® Rest and Stress MPI for the Detection of Myocardial Ischemia in Adolescents and Children Versus Coronary Angiography |
0.35; 0.62; 0.21; 0.77 | — |
| SECONDARY Incidence of Hard Cardiac Events |
0; 0; 0; 0 | — |
| SECONDARY Estimate the Performance of Cardiolite® Rest and Stress MPI for the Detection of Myocardial Ischemia in the Left Anterior Descending (LAD) Artery in Adolescents and Children Versus Coronary Angiography |
.25; 0.00; 0.76; 0.74; 0.14; 0.00 | — |
| SECONDARY Predictive Value of Cardiolite For Cardiac Events |
3; 1; 3; 2 | — |
Summary
Determine the predictive value of CARDIOLITE® rest and stress myocardial perfusion imaging (MPI) to define a pediatric population with Kawasaki Disease (KD) at high and low risk of developing cardiac events.
Eligibility Criteria
Inclusion Criteria
- Males or females between 4 and 16
- Meet the epidemiological definition of Kawasaki Disease or have a diagnosis of incomplete KD, including evidence of coronary artery disease as determined by their physician.
- Be able to exercise adequately to achieve 85% age predicted maximum heart rate
Exclusion Criteria
- Terminal illness where expected survival is < 6 months
Data sourced from ClinicalTrials.gov (NCT00162032). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.